The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment

The Novel XOI, Febuxostat: Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment - The NovEl XOI, FebuxostaT; Safety and Tolerability in Patients with Hyperuricemia Associated with Moderate to Severe Renal Impairment (NEXT-STAR)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007088

Enrollment

Registered

2012-01-17

Start date

2012-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia with moderate to severe renal impairment

Interventions

Febuxostat is administered in dose escalation manner as follows, with careful check of safety and tolerability at each dose: - Start 10 mg, once daily - At 4 weeks after starting, dose up to 20 mg,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gout or hyperuricemia patients eligible for all the points of the following: (1) Japanese male or female, 20 years old or above at the time of informed consent (2) Serum uric acid > 8.0mg/dL (3) eGFR< 45 mL/min./1.73 m2 Moderate (CKD stage 3b) to severe (CKD stage 4-5) renal impairment (4) Not treated with uric acid lowering agent within 1 month before the timing of eligibility judgement (5) Patinets from which informed consent is obtained *: eGFR is calculated based on Japanese GFR formula eGFR (mL/min/1.73 m2) = 194 x Serum creatinine(-1.094) x Age(-0.287) x 0.739 (if female)

Exclusion criteria

Exclusion criteria: (1)Patients having gouty attach at the time of eligibility judgment, or within 2 weeks after being cured from gout attack. (2)Hepatic impairment patients (AST, ALT is more than double of standard values) (3)Patients with unstable renal impairment, (50 % of change in sCR within 3 months), acute renal diseases or dialysis (4)Patients having plan to receive dialysis or renal transplantaion during study (5)Patinets having malignancy or other severe diseases (6)Patients with hypersensitivity to febuxostat (7)Pregnant female, lactation femal, hoping gestation (8)Treated patients with mercaptopurine or azathioprine (9)Patients whom study physicians consider as not eligible.

Design outcomes

Primary

Measure	Time frame
Safety and Torelability: Adverse event, number and incidence Laboratory test Vital sign, Blood Pressure	—

Secondary

Measure	Time frame
Serum uric acid value Change rate of serum uric acid Achievement rate of serum uric acid at 6.0mg/dL or less Change rate of eGFR Protein amount in urine	—

Countries

Japan

Contacts

Public ContactIwao Ohno1),Yugo Shibagaki2)

1) Jikei University School of Medicine, 2) St Marianna University 1)Division of Kidney and Hypertension, 2)Division of Nephrology and Hypertension

i-ohno@jikei.ac.jp03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026